Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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원인
Siemens healthcare diagnostics has confirmed that dimension creatinine (cre2) assay and dimension vista creatinine (cre2) assay exhibits a negative bias at the low end of the urine analytical measurement range (amr). the limit of quantitation (loq) claim (5 mg/dl [442 umol/l]) for urine samples is not met. siemens is actively investigating the root cause of the issue and is working to implement a solution. this issue also affects all future lots of cre2 until a solution is implemented. the serum/plasma cre2 amr is not affected by this issue.
Model Catalog: K1033A (Lot serial: ALL LOTS); Model Catalog: 10872082 (Lot serial: ALL LOTS); Model Catalog: 10872079 (Lot serial: ALL LOTS); Model Catalog: DF33B (Lot serial: ALL LOTS)
제품 설명
DIMENSION VISTA SYSTEM CREATININE (CRE2) FLEX REAGENT CARTRIDGE;DIMENSION CLINICAL CHEMISTRY SYSTEM CREATININE (CRE2) FLEX REAGENT CARTRIDGE